Senseonics Holdings, Inc. Q4 FY2024 earnings call

• In 2024, Senseonics made strong progress with the US approval of Eversense 365 in September, a world-first once-yearly CGM. They filed for CE Mark approval for Eversense 365 with plans for European launch in the second half of 2025.
• Pipeline programs include Gemini (one-year sensor with battery for continuous and swipe testing) with feasibility study expected to complete in 2024 and IDE submission for pivotal study by year-end, and Freedom (sensor with Bluetooth for direct phone communication).
• Partnerships with Mercy Health and SweetSpot, and progress with insulin pump manufacturers on integration.
• 2024 performance metrics: Patient base increased 56% to ~6,000 global patients, US Eversense prescribers exceeded 2,400 (73% increase from prior year), direct-to-consumer leads increased 40%, new patient shipments over 3,000, and 81% of patient base switched from competitive CGMs. 69% of new users in 2024 were Type 2 diabetes patients.
• Commercial strategy pillars: Direct-to-consumer marketing, marketing to healthcare professionals, collaboration with hospital systems, and retention/renewal of existing users.

In the fourth quarter of 2024, net revenue was $8.3 million, with US revenue at $6.2 million and revenue outside the US at $2.1 million. Gross profit was $4 million. For the full year 2024, total revenue was $22.5 million, with US revenue at $15.3 million and revenue outside the US at $7.2 million. Gross profit was $0.5 million. The consignment program accounted for approximately 15% of revenue in 2024. Gross profit margins for the fourth quarter 2024, when considering certain manufacturing costs, were north of 25%, and for full year 2024, excluding one-time product transition costs, gross profit margin was more than 16%.

• 2025 global net revenue expected to be approximately $34 million to $38 million as US transitions to Eversense 365 and European launch of 365 occurs.
• Anticipate doubling the global patient base in 2025. Revenue expected to be about one-third in the first half and two-thirds in the second half due to seasonality and patient assistance programs.
• Gross margins expected to steadily increase each quarter in 2025, projected between 25% and 30% for full year.
• Cash utilization in 2025 expected to be between $50 million and $60 million.

Q: On the OUS launch planned for later in the year, what should we expect regarding inventory stocking?

A: Tim Goodnow anticipates it will be more gradual, similar to the US build-up, with Europe planned to be built conservatively.

Q: On Mercy and prescriber base, what's being seen on the ground?

A: There's excitement around 365, transitioned from endocrinology to primary care, with more work needed to reach broader prescriber population.

Q: Clarification on prescribers: Difference between 1,000 prescribers since launch and 2,400 annual prescribers?

A: Rick Sullivan explains 1,000 was prescribers since launch, 2,400 was annual number.

Q: Revenue growth from international vs US?

A: Most growth will continue from US, but significant increase expected with European 365 launch.

Q: Qualitative update on reimbursement efforts, especially at Medicare?

A: Working arduously on reimbursement, G-codes published, working on pricing, anticipating resolution over next quarter or so.